Kornimate/medical-research-clean huggingface dataset:
study of cariprazine oral capsules or solution to assess adverse events and change in irritability due to autism spectrum disorder (asd) in participants aged 5-17 years with asd

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorder (asd) consists of deficits in social, communication, and cognitive development, repetitive and stereotypic behaviors. many asd patients show notably high levels of irritability, including verbal and physical aggression, self injury, and/or property destruction. autistic infants tend to avoid eye contact and show little interest in others. this study will assess how safe and effective cariprazine is in treating pediatric participants (5 to 17 years of age) with asd. adverse events and change in disease activity will be assessed. cariprazine is an investigational drug being developed for the treatment of irritability due to asd. this study is double-blinded means that neither the participants nor the study doctors will know who will be given cariprazine and who will be given placebo (does not contain treatment drug). study doctors put the participants in 1 of the 2 groups, called treatment arms. each group receives a different treatment. there is a 1 in 2 chance that participants will be assigned to placebo. approximately 152 participants diagnosed with asd will be enrolled in approximately 40 sites globally. participants will receive oral capsules or oral solution of cariprazine or placebo once daily for 8-weeks and will undergo a 4-week safety follow-up period. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * participants at the time of screening must have a diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) diagnosis of asd, confirmed by kiddie schedule for affective disorders and schizophrenia-present and lifetime (k-sads-pl) administered at screening (visit 1) by a trained clinician. * participants must have an aberrant behavior checklist, 2nd edition - community version - irritability (abc-i) subscale score ≥ 18 (visits 1 and 2). * participants must have a clinical global impressions - severity - irritability (cgi-s irritability) score ≥ 4 at screening (visits 1 and 2). exclusion criteria: * participants with diagnosis of intellectual disability (intelligence quotient \< 25). * no history of major depressive disorder, bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition, as excluded by administration of kiddie schedule for affective disorders and schizophrenia-present and lifetime (k-sads-pl). * history of asd that is associated with rett disorder, fragile-x syndrome, or childhood disintegrative disorder.

Keywords: autism spectrum disorder cariprazine vraylar agn-241780
effect of hip strengthening exercises and pelvic floor exercises on stress urinary incontinence in postnatal women

Conditions: Stress Urinary Incontinence

Summary: this study will investigate effect of hip strengthening exercises and pelvic floor exercises on stress urinary incontinence in postnatal women. clinical practice guidelines recommend pfmt as the first-line treatment for female sui . also, it has been speculated that the hip muscles are involved in the continence mechanism and that their deficiency could destabilize the normal function of the system. the addition of hip muscle exercises, regardless of pfm contractions, aimed to improve muscular condition for the motor or synergic strategies in pfm contraction. secondary effects of these techniques, such as the influence of passive lumbar rotational mobilization in improving hip flexor strength, have been of high interest in physiotherapy in general


Eligibility criteria:
inclusion criteria: 1. their ages will be ranged from 30 to 35 years old. 2. their bmi will not exceed 35 kg/m2. 3. all patients will be multipara women. 4. their deliveries were normal vaginal delivery. 5. all patients will be diagnosed by gynecologist as mild or moderate degree of sui. 6. all patients will have the same medical treatment and free from any pathological conditions that might affect the result. exclusion criteria: 1. recurrent urinary tract infections. 2. hypertension. 3. diabetes mellitus. 4. intra uterine device. 5. hysterectomy.
study of renal autologous cell therapy (react) in subjects with type 1 or 2 diabetes and chronic kidney disease (regen-007)

Conditions: Chronic Kidney Diseases; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Summary: the purpose of this study is to assess the safety, efficacy, and durability of up to two react injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with t1dm or t2dm and ckd.

the objective of this study is to assess the safety, efficacy, and durability of up to two react injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with t1dm or t2dm and ckd: * cohort 1: two scheduled react injections given 3 months (+60 days) with at least 18- month follow-up * cohort 2: one scheduled react injection with a possible second react injection, no less than 3 months after the first one, within 30 days (+30 days) of meeting a renal function redose trigger (triggered up to 15 months following the first react injection). both cohorts will be followed for 18 months after the final react injection. if a cohort 2 subject does not meet a trigger, the subject will be followed for at least 18 months after the first injection.

Eligibility criteria:
inclusion criteria: 1. male or female aged 30 to 80 years, inclusive, on the date informed consent is signed. 2. clinical diagnosis of t1dm or t2dm, controlled per institutional standard of care. 3. the subject has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy). 4. the subject has a serum glycosylated hemoglobin (hba1c) level less than 10% at the screening visit. 5. the subject has a documented clinical diagnosis of an egfr between 20 and 50 ml/min/1.73m² inclusive not requiring renal dialysis. exclusion criteria: 1. the subject has a history of renal transplantation. 2. the subject has a mean systolic blood pressure greater than or equal to 140 mmhg and/or mean diastolic blood pressure greater than or equal to 90 mmhg at screening. subjects with blood pressure outside of this range prior to biopsy/injection may continue if approved by the medical monitor. 3. the subject has hemoglobin levels less than 10 g/dl and is not responsive to the standard medical intervention for ckd-related anemia prior to randomization.

Keywords: kidney biopsy react
assessment of the efficacy and tolerability of the fixed-dose combination of bisoprolol/perindopril

Conditions: Arterial Hypertension; CHD - Coronary Heart Disease

Summary: study objective - to assess the efficacy, tolerability and adherence of bisoprolol/perindopril fdc in patients with ht and stable cad in everyday practice. type of the program: multicenter, observational, uncontrolled, open program. the program will involve 480 general practitioners (gps) and cardiologists from the primary care facilities.each doctor includes four patients. it is planned to include not less than 1920 patients in total.

multicenter observational open program. assessment of the efficacy and tolerability of the fixed-dose combination of bisoprolol/perindopril in patients with arterial hypertension and stable cad in daily clinical practice (style) study objectives and purposes: primary endpoints: * efficacy of bisoprolol/perindopril fdc in patients with ht and stable cad in everyday practice regarding the bp * efficacy of bisoprolol/perindopril fdc in patients with ht and stable cad in everyday practice regarding the angina secondary endpoints: * impact on the quality of life of bisoprolol/perindopril fdc in patients with ht and stable cad in everyday practice * adherence to bisoprolol/perindopril fdc therapy in patients with ht and stable cad in everyday practice the program will involve 480 general practitioners (gps) and cardiologists from the primary care facilities. each doctor includes four patients. it is planned to include not less than 1920 patients in total. milestones of the program: fsi - november, 2018 lslv- january, 2019 database lock - february, 2019 statistic report- may, 2019 clinical study report- january, 2020

Eligibility criteria:
inclusion criteria: * stable cad, defined as stable angina pectoris of class 1-3 by ccs (canadian cardiovascular society) classification; * previously or newly diagnosed essential hypertension * age 18 to 79 years old; * informed consent of the patient for participation in the program; * decision of the doctor to prescribe bisoprolol/perindopril fdc before the inclusion in the program in accordance to the instruction for use. exclusion criteria: * stable angina pectoris, class 4; * history of myocardial infarction or cerebrovascular event within the past 3 months; * unstable angina within the past 6 months; * chronic heart failure classes 3-4 (nyha); * type 1 diabetes mellitus or decompensated type 2 diabetes mellitus; * any serious decompensated concomitant diseases requiring the regular medical therapy; * inability to understand the essence of the program and follow the recommendations; * contraindications to beta-blockers or ace inhibitors using; * participation of the patient in other trials in the present time or within 30 days before the start of observational program.
taking action together- a diabetes prevention program

Conditions: Type 2 Diabetes

Summary: the purpose of this study was to determine whether once-weekly exposure to a program that fostered self-esteem building, and improvements in nutrition and physical activity behaviors would reduce risk of type 2 diabetes in overweight, inner-city, african american children when compared to a control group.

in the united states and, indeed, worldwide the prevalence of overweight and obesity has increased at an unprecedented rate. concomitant with this demographic change are increases in diseases including type 2 diabetes, cardiovascular disease and some cancers that are associated with body fatness. strategies to reduce body weight have been largely unsuccessful, making it unlikely that our population will be made healthy simply by recommending that overweight people reduce their body fatness. there is evidence, however, that the impact of body fat on human health can be significantly attenuated by potentially achievable strategies. such strategies require adequate intakes of essential nutrients, regular physical activity and strong self-esteem. the goal of the project is to reduce the risk of type 2 diabetes mellitus (t2dm) in overweight 9- to 10-year-old african american children through a multi-component community-based program. the specific objectives are to (1).implement a randomly controlled 2-phase intervention involving a 2-week summer camp, and weekly \& monthly reinforcement sessions over 2 years, that include nutrition education, physical activity promotion, and self-esteem and self-efficacy building and (2) test effectiveness of the program after 1 and 2 years of intervention on insulin sensitivity, the primary outcome, and on secondary outcomes including body fatness, dietary intakes, physical activity, and self-esteem. identifying an effective, community-based program that could reduce risk of type 2 diabetes in high-risk children would promote health, reduce disease and reduce health-care costs in the future.

Eligibility criteria:
inclusion criteria: * child age of 9-10 yr old at baseline * child bmi at least 85th percentile when matched for age and gender * able and willing to participate in normal daily activities * living in inner-city regions of oakland ca exclusion criteria: * fasting blood glucose of 120 mg/dl or higher * diagnosis of diabetes or other central metabolic disease * taking medications that interfere with or treat main study outcomes

Keywords: obesity nutrition type 2 diabetes community-based.
a post approval commitment study on tabrecta® (capmatinib) in south korea

Conditions: Non-Small-Cell Lung Carcinoma

Summary: this is an open label, prospective, multicenter, non-comparative study to assess the safety and effectiveness of tabrecta® (capmatinib) in real world setting. also, this study is to fulfill the regulatory requirements as part of the rmp (risk management plan) for tabrecta® (capmatinib), as requested by korea health authority, mfds (ministry of food and drug safety).

the study is a post approval surveillance so there will be no comparator arm/drug nor blinding process. dose/regimen should follow locally approved label and it could be adjusted as per the decision from treating physician during treatment period, under their routine clinical practice. treatment duration is deemed to the decision from treating physician under their routine clinical practice, since this study is a post approval surveillance and to look for safety profiles happening under real world practice. there will be no intervention from novartis regarding dose/regimen and treatment duration. this study will be completed after data collection of the last subject during the follow up period. the follow up period is recommended for up to 24 weeks after enrollment or up to the time of discontinuation of study drug (in case of early discontinuation) as per linical judgement of treating physician.

Eligibility criteria:
inclusion criteria: * signed informed consent must be obtained prior to participation in the study. * subject who are diagnosed as exon 14 skipping mutated nsclc from tissue or plasma(ctdna) sample analysis by treating physician (i.e. any kind of diagnostic methods the institution currently has. diagnostic modalities for research purpose would be also allowable.) * subject who plan to receive tabrecta® (capmatinib) as per locally approved label exclusion criteria: * subject with contraindication according to the locally approved label * subject whose medical record is not accessible * subject who are not willing to provide informed consent

Keywords: non small cell lung non small cell lung cancer non-small cell lung cancer nsclc inc280 non-small cell lung carcinoma (nsclc) lung cancer lung adenocarcinoma non small cell lung carcinoma met exon 14 deletion metex14del met exon 14 skipping met exon 14 mutation met mutation met amplification met inhibitor met dysregulation met activation met signaling met pathway
ear pressure points plus pain meds for faster kidney stone pain relief

Conditions: Renal Colic; Acupuncture, Ear

Summary: title: can ear acupressure help relieve kidney stone pain faster when combined with painkillers? purpose: this study tests whether adding ear acupressure to standard painkillers (nsaids) helps adults with kidney stone pain feel better faster. the investigators also want to know if this combination causes any side effects. key questions: does ear acupressure + nsaids reduce pain more quickly than nsaids alone? are there any safety concerns with this treatment? how does real ear acupressure compare to a fake (placebo) procedure? who can join? adults aged 18-75 experiencing moderate-to-severe kidney stone pain (confirmed by ct or ultrasound) no recent painkiller use or allergies to nsaids what participants will do: receive in the emergency room: real treatment: tiny needles placed on 3 ear points + nsaids (ketorolac injection) or placebo treatment: fake tape on ear points + nsaids (same injection) rate their pain on a 0-10 scale over 60 minutes. have their heart rate and blood pressure checked. study details: duration: single er visit (no long-term follow-up) participants needed: 116 safety: rescue pain medication (like morphine) is available if needed. why this matters: kidney stones cause severe pain, and current painkillers may not work fast enough. ear acupressure is a low-risk method from traditional chinese medicine that could provide quicker relief. ethics: approved by changhai hospital's ethics committee. participants can leave the study anytime.


Eligibility criteria:
inclusion criteria: 1. age between 15 and 75 years (inclusive) 2. diagnosis of urinary tract stones confirmed by ct or ultrasound 3. visual analog scale (vas) score ≥ 4 (indicating moderate to severe renal colic) 4. no severe cardiac, hepatic, or pulmonary dysfunction, and no coagulation disorders. 5. no psychiatric disorders exclusion criteria: 1. use of any analgesic medication within the past 6 hours. 2. allergy to nsaids, morphine, or anisodamine (scopolamine derivatives) 3. history of asthma, urticaria, congestive heart failure, acute ischemic heart disease, acute cerebrovascular disease, or increased intracranial pressure 4. active peptic ulcer, pyloric obstruction, or intestinal obstruction 5. severe adverse reactions to acupuncture in the past 6. pregnancy or lactation 7. unwillingness to sign informed consent

Keywords: kidney calculi renal colic acupuncture, ear
evaluation of medium cross-linked polyethylene with and without vitamin e for total knee arthroplasty

Conditions: Osteoarthritis, Knee; Arthritis, Rheumatoid; Intra-Articular Fractures; Joint Instability; Genu Valgum or Varum

Summary: prospective, randomized, single-blind, multinational, long-term study for the evaluation of the clinical outcome, oxidation profile and wear analysis of medium cross-linked polyethylene with and without vitamin e for total knee arthroplasty


Eligibility criteria:
inclusion criteria: * indication for a total knee replacement with a mobile-bearing uc or ps inlay * written informed consent for participating at the clinical study * willingness and mental ability to participate at the long-term follow-up examinations exclusion criteria: * patient age \ 80 years * pregnancy * high risk patients (asa class \>3)

Keywords: total knee arthroplasty range of motion treatment outcome ultrahighmolecular weight polyethylene with vitamin e
can recurrence of cancer in the oropharynx be detected by blood samples?

Conditions: Oropharyngeal Squamous Cell Carcinoma (SCC); Oropharynx Cancer; Oropharynx Cancer, Metastatic; Oropharynx Cancer, Recurrent; Oropharyngeal Carcinoma

Summary: this study investigates if longitudinal analyses of cell-free hpv-dna in blood samples can be utilized to detect recurrence in patients diagnosed and treated for hpv-positive oropharyngeal squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: * patients with newly diagnosed hpv+ (or p16+) opscc carcinoma originating from the oropharynx * above 18 years of age * informed consent * patients offered curative treatment. exclusion criteria: * the patient does not speak or understand danish * the patient has another disease/condition considered a reason for exclusion

Keywords: hpv hpv-dna liquid biopsy cell-free hpv-dna circulating hpv-dna
reduced dose of pegfilgrastim as support for chemotherapy for breast cancer

Conditions: Neutropenia

Summary: pegfilgrastim is a long-acting recombinant human granulocyte-colony stimulating factor as support for chemotherapy, which can be used conveniently. according to the package inserts in america, europe, and china, the recommended dose for pegfilgrastim is 6mg per cycle, while it is recommended at a dose of 3.6mg in japan. it is still unclear whether pegfilgrastim 3mg can produce similar efficacy with pegfilgrastim 6mg. in this trial, the investigators prospectively compared the efficacy and safety of pegfilgrastim 3mg with 6mg in patients with breast cancer receiving ac regimen, a commonly used regimen in adjuvant chemotherapy for breast cancer.

all patients received ac regimen (epirubicin or pirarubincin in combination with cyclophosphamide) intravenously. epirubicin 90mg/m\^2 (or pirarubicin 60mg/m\^2) and cyclophosphamide 600mg/m\^2 were administered on day 1 of the chemotherapy cycle. ac regimen was administered bi-weekly or 3-weekly. eligible patients were randomly assigned to 3mg arm (the study arm) and 6mg arm (the control arm) in a 1:1 ratio, stratified according to body weight (≤60kg or \>60kg). patients in the study arm and the control arm received a subcutaneous injection of 3mg peg-rhg-csf and 6mg, respectively, forty-eight hours after completing chemotherapy infusion.

Eligibility criteria:
inclusion criteria: * female aged 18-69 years * diagnosed pathologically as early breast cancer * with indication for adjuvant chemotherapy and suitable for ac regimen (epirubicin and cyclophosphamide, or pirarubicin and cyclophosphamide, planned chemotherapy with taxanes after ac regimen were allowed) * received no prior chemotherapy (chemotherapy naïve) * have karnofsky performance status ≥ 80, * baseline hemoglobin ≥90g/l, white blood cell count ≥4.0x10\^9/l,anc≥2.0x10\^9/l, platelet count ≥100x10\^9 * adequate cardiac, hepatic and renal function exclusion criteria: * enrolled onto or had not yet completed other investigational drug trials * allergic to any component of peg-rhg-csf injection, or other biological products derived from genetically engineering escherichia coli; * pregnant or lactating women; * previous large volume radiotherapy, or prior bone marrow or stem-cell transplantation
lung structure-function in survivors of mild and severe covid-19 infection: 129xe mri

Conditions: COVID-19 Respiratory Infection

Summary: in this study the investigators aim to deploy ute and hp 129xe mri for structural and functional evaluation of persistent lung abnormalities in covid-19 survivors.

what is covid-19? the ongoing coronavirus disease 2019 (covid-19) pandemic is caused when an individual is infected with the sars-cov-2 virus. this infection can result in pneumonia involving the small airways and alveoli (the tiny air sacs at the end of the airways that help oxygen get into the blood). covid-19 can cause damage to the lungs, making it hard to breathe without medical help. to understand what is happening to a patient's lungs, doctors may use imaging tests such as chest x-rays or ct scans (computed tomography). however, these types of tests may not tell the investigators the whole story. what is the purpose of the study? led by the hospital for sick children (sickkids), this study is being done to determine if mri (magnetic resonance imaging) scans can tell the investigators more about the lungs of people who had covid-19. the investigators will use a special type of mri where participants breathe in a special gas (hyperpolarized xenon-129) before they have the mri. this gas will help the investigators to see' the lungs. the advantage of mri scans is that there is no radiation involved in these types of images. what is involved? in this study, participants will have an mri of their lungs. the investigators will examine these mri scans to see if the investigators can identify any changes in the structure or the function of the lung. if the investigators do find any changes, they will see how these changes relate to other tests that have been conducted or other parts of the clinical story. the participants will be asked to come to sickkids for 3 study visits. a fourth visit will be conducted via telephone. these visits will span over 3 years. each study visit will take about 4 hours. if the participant is unable to attend one of the in-person visits, they will be given the option for a phone/virtual visit instead.

Eligibility criteria:
inclusion criteria: * consent provided * aged 12-70 years old * meets mri screening criteria * diagnosed with covid19, documented by positive covid19 test (nasopharyngeal swab or saliva swab) and are within 3 months post recovery\*. * recovery from covid19 is defined as asymptomatic for at least 2 weeks prior to study visit 1 and screen negative based on sickkids guidelines. exclusion criteria: * pregnant or lactating\* * a cold or flu within the last 2 weeks

Keywords: lung mri 129xenon